• Extremity, trunk, head and neck
• Retroperitoneal, intra-abdominal
• Gastrointestinal stromal tumor (GIST)
• Desmoid tumor (aggressive fibromatoses)
• Rhabdomyosarcoma

(NOTE: This policy only applies to adult members. It does not apply to pediatric members.

For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

1. Extremity, trunk, head and neck sites
   1. Preoperative radiation therapy with photons and/or electrons
      
      Radiation therapy with photons and/or electrons is considered medically necessary when delivered prior to resection or attempted resection of a soft tissue sarcoma of an extremity, the trunk, or a head and neck site. At the time of surgery, clips should be placed to both identify the periphery of the surgical field and also to identify any potential sites of microscopic or gross residual disease that may be in need of higher amounts of radiation.
      
      The medically necessary pre-operative dose is 50 Gy using conventional fractionation of 1.8 Gy to 2 Gy per day followed by a post-operative boost that depends on the extent of any disease remaining after resection.
      
      Indications and doses medically necessary for a boost due to positive margins are the following:
      
      1. External beam radiation therapy with photons and/or electrons:
         1. For microscopic residual disease (R1 resection) 16 Gy to 18 Gy.
         2. For gross residual disease (R2 resection) 20 Gy to 26 Gy.
      2. Brachytherapy - low dose rate (LDR):
         1. For microscopic residual disease (R1 resection) 16 Gy to 18 Gy.
         2. For gross residual disease (R2 resection) 20 Gy to 26 Gy.
      3. Brachytherapy - high dose rate (HDR):
         1. For microscopic residual disease (R1 resection) 3 Gy to 4 Gy given twice daily for a total of 14 Gy to 16 Gy.
         2. For gross residual disease (R2 resection) 3 Gy to 4 Gy given twice daily for a total of 18 Gy to 24 Gy.
      4. Intra-operative radiation therapy (IORT) with photons and/or electrons:
         1. For microscopic residual disease (R1 resection) 10 Gy to 12.5 Gy.
         2. For gross residual disease (R2 resection) 15 Gy.
            
   2. Post-operative radiation therapy with photons and/or electrons (all radiation treatments planned to be given during and/or after resection).
      
   3. Radiation therapy is medically necessary when delivered at the time of or subsequent to resection or attempted resection of a soft tissue sarcoma of an extremity, the trunk, or a head and neck site. At the time of surgery, clips should be placed to both identify the periphery of the surgical field and also to identify any potential sites of microscopic or gross residual disease that may be in need of higher amounts of radiation, if anything other than an R0 (negative margins) was anticipated. Indications and doses medically necessary for post-operative radiation therapy are the following:
      1. External beam radiation therapy with photons and/or electrons - 50 Gy using conventional fractionation of 1.8 Gy to 2 Gy per day followed by a boost:
         1. For microscopically positive margins 16 Gy to 18 Gy.
         2. For gross residual disease 20 Gy to 26 Gy.
      2. LDR Brachytherapy:
         1. For positive surgical margins 16 Gy to 20 Gy followed by 50 Gy external beam radiation therapy using with photons and/or electrons with conventional fractionation of 1.8 Gy to 2 Gy per day.
         2. For negative margins 45 Gy. No boost is medically necessary.
      3. HDR Brachytherapy:
         1. For positive surgical margins 3 Gy to 4 Gy given twice daily for a total of 14 Gy to 16 Gy followed by 50 Gy external beam radiation therapy using photons and/or electrons using conventional fractionation of 1.8 Gy to 2 Gy per day.
         2. For negative margins 36 Gy given in 10 fractions on a twice-daily basis, 3.6 Gy per fraction. No boost is medically necessary.
      4. IORT with photons and/or electrons - 10 Gy to 16 Gy followed by EBRT of 50 Gy external beam radiation therapy using photons and/or electrons with conventional fractionation of 1.8 Gy to 2 Gy per day.
         
         
2. Retroperitoneal and intra-abdominal sites (excluding desmoid tumors):
   1. Pre-operative radiation therapy with photons:
      
      With the exception of desmoid tumors, radiation therapy with photons is medically necessary when delivered prior to resection or attempted resection of a soft tissue sarcoma of a retroperitoneal or intra-abdominal location. At the time of subsequent surgery, clips should be placed to both identify the periphery of the surgical field and any potential sites of microscopic or gross residual disease that may be in need of higher amounts of radiation.
      
      Two dose schedules/techniques are medically necessary:
      1. The pre-operative dose is 50 Gy using conventional fractionation with photons of 1.8 Gy to 2 Gy per day, followed by a post-operative boost of photons that depends on the extent of any disease remaining after resection.
      2. A pre-operative dose-painting technique with photons is medically necessary to deliver the following:
         1. Coverage of the entire clinical target volume (CTV) to a dose of 45 Gy to 50 Gy in 25 to 28 once-daily fractions.
         2. Simultaneous integrated boost to anticipated high risk margins to a dose of 57.5 Gy.
   2. IORT with photons and/or electrons:
      1. IORT with photons and/or electrons - 10 Gy to 16 Gy followed by external beam radiation with photons and/or electrons of 50 Gy using conventional fractionation of 1.8 Gy to 2 Gy per day.
         1. IORT with photons and/or electrons:
            1. For microscopically positive margins: 10 Gy to 12.5 Gy.
            2. For gross residual disease: 15 Gy.
   3. Post-operative radiation therapy with photons:
      
      Radiation therapy with photons is medically necessary when delivered subsequent to resection or attempted resection of a soft tissue sarcoma of a retroperitoneal or intra-abdominal location. At the time of surgery, clips should be placed to both identify the periphery of the surgical field and to help define potential sites of microscopic or gross residual disease that may benefit from additional radiation.
      
      Indications and doses medically necessary for post-operative radiation therapy with photons are the following:
      1. External beam radiation therapy with photons of 50 Gy using conventional fractionation of 1.8 Gy to 2 Gy per day, followed by a boost:
         1. For select cases with negative margins (R0): 10 Gy with photons.
         2. For microscopically positive margins (R1): 16 Gy to 18 Gy with photons.
         3. For gross residual disease (R2 and re-resection not possible): 20 Gy to 26 Gy with photons.
3. Treatment of primary or metastatic sites for salvage or palliation
   
   Palliation of recurrent or metastatic sites of soft tissue sarcoma may be medically necessary when other alternatives are less appropriate. The use of radiation in such circumstances must balance between expedience, the need and ability to relieve symptoms, the high doses that are required to achieve a response, and the potential normal tissue damage that can be inflicted. All requests for the palliative use of radiation with photons that involve Intensity-Modulated Radiation Therapy (IMRT), Stereotactic Body Radiation Therapy (SBRT), or more than 15 fractions require medical review. Palliative treatment with electrons is done with Complex Radiation Therapy technique and should not exceed 15 fractions.
4. Radiation techniques
   1. Three-dimensional conformal radiation therapy (3DCRT):
      3DCRT with photons is medically necessary in all cases of curative intent in order to limit the radiation dose to normal nearby organs at risk (OARs). 3DCRT is also medically necessary for palliative treatment of soft tissue sarcomas.
      
   2. IMRT:
      IMRT is considered medically necessary in the treatment of retroperitoneal sarcomas.
      
   3. IORT:
      IORT is medically necessary when given in conjunction with external beam radiation therapy with photons and/or electrons and is not regarded as medically necessary as a sole means of delivering radiation therapy to a soft tissue sarcoma. IORT requires special technology in that it is delivered in a single fraction to the tumor or tumor bed during the surgical procedure being performed to resect the sarcoma.
      
   4. Brachytherapy:
      Brachytherapy may be given using an HDR approach or an LDR approach and is medically necessary in cases in which a boost is required or as the sole means of delivering radiation for tumors that have been completely resected with clear margins.
      
      When HDR is utilized, afterloading catheters are placed at the time of surgery, and the radioactive sources are briefly placed within them multiple times, most commonly twice daily, for several days. One placement of HDR afterloading catheters is medically necessary, as is up to six loadings of the radioactive sources into them.
      
      When utilized, LDR brachytherapy is performed by placing radioactive material permanently into the region of the tumor. As the radioisotope decays fully, the radiation dose is delivered; the material becomes non-radioactive and can be left in place. One LDR insertion is medically necessary.
      
   5. SBRT:
      SBRT with photons is medically necessary to treat a locally recurrent soft tissue sarcoma that is within or immediately adjacent to an area that has received radiation treatments as part of the primary management.
      
      For SBRT treatment of metastases, please refer to a separate policy on 'Radiation Treatment of Oligometastases' Policy #147 in the Radiology Section.
      
   6. Image-Guided Radiation Therapy (IGRT):
      
      (NOTE: Please refer to a separate policy on 'Image-Guided Radiation Therapy - IGRT' - Policy #139 in the Radiology Section.)
   
   

Radiation therapy with photons and/or electrons is medically necessary in palliative cases of soft tissue sarcoma of the extremity, trunk, head and neck, retroperitoneal and intra-abdominal sites when other simpler methods of palliation are inadequate, ineffective, or not available.

Radiation therapy is not medically necessary in the initial management of GIST but does have a role in management of refractory or unresectable cases.

Radiation therapy with photons and/or electrons may play a role in the management of desmoid tumors but is generally limited to sites other than retroperitoneal or intra-abdominal.

Of the rhabdomyosarcomas, management of the pleomorphic variety is similar to that of other soft tissue sarcomas. The non-pleomorphic variety often occurs in the pediatric population, and its management is less well defined.

Treatment is to be given in a multidisciplinary environment in which the radiation oncologist is consulted prior to a resection attempt.

Medically necessary radiation therapy with photons and/or electrons employs the use of highly sophisticated treatment planning and the use of highly conformal delivery techniques to achieve a suitable therapeutic ratio of target coverage versus protection of normal tissues. Radiation dose is to be influenced by normal tissue tolerance, i.e. doses listed herein may require modification based on normal tissue constraints.

Radiation therapy is not a substitute for completeness of resection. Re-resection may be indicated in some cases. However, further resection may not be feasible for medical or technical reasons and this may serve as an indication for additional radiation (boost) in selected cases. Examples include extremely large tumors, high-grade lesions, or the morbidity of further surgery. The risk and feasibility of administering additional radiation must be weighed against that of additional surgery. Means to mitigate radiation to nearby structures, such as tissue displacement using omentum, biologic or synthetic material, may be incorporated into the resection procedure when additional postoperative radiation is contemplated.
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Radiation Therapy for Soft Tissue Sarcomas
Radiation Treatment of Soft Tissue Sarcomas
Soft Tissue Sarcomas, Radiation Treatment
Sarcomas, Soft Tissue, Radiation Treatment
Sarcomas, Stereotactic Radiotherapy
Soft Tissue Sarcomas, Stereotactic Radiotherapy
Stereotactic Radiotherapy, Soft Tissue Sarcomas
Stereotactic Radiotherapy, Sarcomas
SBRT, Soft Tissue Sarcomas
SBRT, Sarcomas

References:
1. Al Yami A, Griffin AM, Ferguson PC, et al. Positive surgical margins in soft tissue sarcoma treated with preoperative radiation: Is a postoperative boost necessary? Int J Radiat Oncol Biol Phys. 2010 Jul 15; 77(4):1191-1197.

2. Alektiar KM, Brennan MF, Healey JH, et al. Impact of intensity-modulated radiation therapy on local control in primary soft-tissue sarcoma of the extremity. J Clin Oncol. 2008 Jul 10; 26(20):3440-3444.

3. Amin, BA. Brookland RK, Byrd DR, et al. Part IX Soft Tissue Sarcoma. In: Amin, BA. Brookland RK, Byrd DR, et al., eds. The AJCC Cancer Staging Manual. 8th ed. Chicago, IL: Springer; 2018:489-548.

4. Baldini EH. Soft Tissue Sarcoma (Excluding Retroperitoneum). In: Halperin EC, Wazer DE, Perez CA, et al., eds. Perez and Brady’s Principles and Practice of Radiation Oncology. 6th Edition. Philadelphia, PA: Lippincott Williams & Wilkins, a Wolters Kluwer business, 2013: Chapter 83:1617-1631.

5. Catton C, Davis A, Bell R, et al. Soft tissue sarcoma of the extremity. Limb salvage after failure of combined conservative therapy. Radiother Oncol. 1996 Dec; 41(3):209-214.

6. Chung CS, Trofimov A, Adams J, et al. A comparison of 3D conformal radiation therapy, intensity modulated proton therapy, and intensity modulated photon therapy for retroperitoneal sarcomas. Int J Radiat Oncol Biol Phys. 2006; 66(3S):S116. Abstract 207.

7. Folkert MR, Singer S, Brennan MF, et al. Comparison of local recurrence with conventional and intensity-modulated radiation therapy for primary soft-tissue sarcomas of the extremity. J Clin Oncol. 2014 Oct 10; 32(29):3236-3241.

8. Haas RML, DeLaney TF, O’Sullivan B, et al. Radiotherapy for management of extremity soft tissue sarcomas: Why, when, and where? Int J Radiat Oncol Biol Phys. 2012 Nov 1; 84(3):572-580.

9. Kraybill WG, Harris J, Spiro IJ, et al. Phase II study of neoadjuvant chemotherapy and radiation therapy in the management of high-risk, high-grade, soft tissue sarcomas of the extremities and body wall: Radiation Therapy Oncology Group Trial 9514. J Clin Oncol. 2006 Feb 1; 24(4):619-625.

10. Marks LB, Yorke ED, Jackson A, et al. Use of normal tissue complication probability models in the clinic. Int J Radiat Oncol Biol Phys. 2010 Mar 1; 76(3S):S10-S19.

11. Musat E, Kantor G, Caron J, et al. Comparison of intensity-modulated postoperative radiotherapy with conventional conformal radiotherapy for postoperative retroperitoneal sarcoma] (original article published in French). Cancer Radiother. 2004 Aug; 8(4):255-261.

12. Nag S, Shasha D, Janjan N, et al. The American Brachytherapy Society recommendations for brachytherapy of soft tissue sarcomas. Int J Radiat Oncol Biol Phys. 2001 Mar 15; 49(4):1033-1041.

13. National Comprehensive Cancer Network (NCCN) Guidelines^® Version 5.2019 – January 23, 2020. Soft Tissue Sarcoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Soft Tissue Sarcoma Version 5.2019. 2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines^® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN^®. To view the most recent and complete version of the NCCN Guidelines^®, go online to NCCN.org.

14. Torres MA, Ballo MT, Butler CE, et al. Management of locally recurrent soft-tissue sarcoma after prior surgery and radiation therapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15; 67(4):1124-1129.

15. von Mehren M, Randall RL, Benjamin RS, et al. Soft tissue sarcoma, version 2.2014, J Natl Compr Canc Netw. 2014 Apr; 12(4):473-483.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*