Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT)

Study Protocol A - IMRT Post Prostatectomy: Patients with prostate cancer (post prostatectomy) Study Protocol B - IMRT Anal Cancer: Patients with anal cancer Study Protocol C - IMRT Nasopharynx: Patients with nasopharynx cancer Study Protocol D - IGRT Intact Prostate: Patients with prostate cancer

Study Protocol A: IMRT versus 3DCRT in Post-Prostatectomy Inclusion Criteria

All of the following must apply:

• Patient has provided written informed consent
• Prior RP for adenocarcinoma of the prostate.
• Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (RP specimen).
• Patients must have at least one of the following risk factors:
• Positive margins
• Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
• PSA nadir ≤ 1.0 ng/ml following RP
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
• Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
• 18 years or older

Exclusion Criteria

None of the following must apply:

• Previous pelvic RT or surgery ie previous rectal or bladder resection
• Concurrent or previous malignancy within 5 years prior to registration (except non-melanomatous skin cancer)
• Androgen deprivation (AD) prior to or following RP as this will affect QoL
• Evidence of nodal or distant metastases
• Clinical or imaging evidence of local recurrence
• Planned adjuvant RT to cover pelvic lymph nodes
• PSA >1.0 ng/ml
• Co-morbidities that would interfere with the completion of treatment
• Concurrent cytotoxic medication
• Hip prosthesis

Study Protocol B: IMRT versus 3DCRT in Anal Cancer Inclusion Criteria

All of the following must apply:

• Informed consent for prospective patients (QoL component)
• Age 18-80 years of age
• Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
• Histological confirmation of squamous cell carcinoma or basaloid carcinoma
• T2-4N0, TanyN2 (ipsilateral groin nodes) and TanyN3 (bilateral groin nodes).
• Intention to elective irradiate all pelvic nodal groups up to L5-S1 interspace (including mesorectal, presacral, internal iliac, external iliac, ischiorectal fossa, obturator and inguinal groups).
• Planned for radical chemoradiation.

Exclusion Criteria

None of the following must apply:

• Evidence of metastatic disease
• Prior pelvic RT/ surgery (e.g. vaginal hysterectomy)
• Presence of hip prosthesis
• Acquired immunodeficiency syndrome (AIDS). HIV patients without AIDS eligible.
• Previous pelvic cancers

Study Protocol C: IMRT versus 3DCRT in Nasopharynx Inclusion Criteria

All of the following must apply:

• Informed consent for prospective patients (QoL component)
• Age >18 years
• Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
• Histologically confirmed carcinoma of the nasopharynx, types WHO1-111, Stage I-IVB
• Adequate staging of local disease (MRI of primary must be performed, imaging of neck nodes with CT with contrast and/or PET-CT) and exclusion of distant metastatic disease (to be confirmed by either whole body PET-CT or a chest CT, and upper abdominal CT or ultrasound scan for patients with abnormal liver function tests or a bone scan or FDG-PET for patients with bone pain).
• Disease must be considered potentially curable by chemoradiation
• Patients must be medically fit for cisplatin chemotherapy according to local practice (adequate renal, cardiac function, no significant neurological co-morbidities)
• Performance status ECOG 0, 1 or 2.

Exclusion Criteria

• Previous head and neck RT or major surgery
• Prior chemotherapy < 6 months from study entry

Study Protocol C: IGRT versus non-IGRT in Intact Prostate Inclusion Criteria

• Patient has provided written informed consent
• Aged 18 years or older
• Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
• Histological diagnosis of carcinoma of the prostate < 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung
• Intermediate risk prostate cancer (that is, T1-2a, Gleason score ≤ 6, PSA 10.1-20.0 ng/ml; T2b-c, Gleason ≤6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ ml)

Exclusion Criteria

• Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection.
• Previous pelvic RT or surgery (eg abdomino-perineal resection)
• Hip prosthesis
• Inflammatory bowel disease
• Previous or current use of AD