RADIATION THERAPY ONCOLOGY GROUP RTOG 95-14 A 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 Neoadjuvant Chemotherapy (MAID) Concurrent Radiation Therapy Two RT cycles of 22 Gy in 11 fractions in 13-15 days starting three days after each of the first two cycles of preoperative chemotherapy, total dose 44 Gy. Postoperative Radiation Therapy (for Positive Margins) Starting 14 days after surgery assuming wound healing is good, 16 Gy will be given by external beam (2 Gy x 8 fractions). Patients with negative surgical margins will not receive boost. RADIATION THERAPY 6.1 General Guidelines 6.1.1 In general, the entire compartment need not be covered. If a margin of 12 cm causes the field to extend beyond the compartment, the field can be shortened to include the end of the compartment plus a margin of 2 cm. 6.1.2 Scars should be bolused with appropriate thickness specific to energy of photon beam. A wider area of bolus should be used if there is subcutaneous or cutaneous involvement. 6.1.3 Needle biopsy sites should be tattooed so that they can be excised at the time of surgery. This should be done in such a way as to not be confused with the isocenter tattoo. 6.1.4 Every effort should be made to: a) Avoid treating the full circumference of an extremity. b) Avoid treating anus, urogenital tract, perineum and genitalia. c) Avoid treating the lung, through use of appropriate shielding and treatment planning. d) Avoid dose maximums in areas where surgical scars will be placed. This requires reviewing treatment plans with the surgeon. e) If possible, avoid treating to full dose, skin over areas commonly traumatized (e.g., the elbow, knee, shin), femoral neck. 6.2 Preoperative Radiation Therapy 6.2.1 Treatment is to consist of two courses of external beam radiation therapy (EBRT) interdigitated between MAID courses 1 and 2 and between courses 2 and 3. Each course of EBRT will begin 3 days after completion of each cycles of MAID course (i.e., 2 days off, out of hospital without therapy) and consist of 22 Gy in 11 fractions (once a day) over 15 days. If it falls on a Saturday or Sunday, treatment can resume on Monday. The total pre-operative irradiation dose will be 44 Gy in 22 fractions. 6.2.2 The target volume of radiation therapy will include the site of the primary lesion and those tissues suspected of involvement by microscopic disease to a clinically important probability. In addition to physical exam findings, MRI scans or CT scans (less desirable) obtained during evaluation will be used in defining the target volume. The margins beyond clinically or radiologically evident sarcoma will be 9 cm. Optimal field arrangement, beam parameters and shaped blocks will be used to achieve the closest approximation of treatment volume to target volume to minimize irradiation of uninvolved normal tissue. 6.2.3 Immobilization devices should be used daily to ensure reproducibility of treatment. 6.3 Post-Operative Radiation Therapy. 6.3.1 Postoperative external beam radiation therapy (EBRT) boost will be given for patients with positive margins. The radiation treatment is to be completed by administering 16 Gy to the bed of the residual tumor (including a margin of 1 cm) . Boost will not be given for patients with 100% necrosis. EBRT will begin approximately 2 weeks following resection, assuming there is satisfactory healing of the surgical wound. At the time of resection, metallic clips will be placed to aid in defining the tumor bed. The target volume for post-operative radiation therapy will be the tumor bed as defined by the operative and pathological findings. Chemotherapy can resume thereafter. 6.3.2 External Beam Post-Operative Boost Guidelines 1) The dose is 16 Gy in 8 fractions (once a day). 2) Bolus can be avoided unless positive margins occur in cutaneous or subcutaneous tissues. 3) It is not necessary to include the entire surgical bed, drain sites and wound. 4) Surgical staples should remain in place during the boost. |