Content - PROSPECT

PROSPECT - Treatment of rectal cancer with combined radiotherapy and chemotherapy or chemotherapy alone, followed in each case by surgical removal of the tumour

The PROSPECT study is concerned with the treatment of rectal cancer. Patients with only a few affected lymph nodes and a tumour that has not yet infiltrated other organs (stages T2 and T3) and can be removed with a safety margin are eligible to enroll.

Such tumours are usually treated by combined radiotherapy and chemotherapy followed by surgical removal of the tumour and subsequent chemotherapy.

The PROSPECT study is investigating whether radiotherapy can be omitted in some patients without impairing their chances of a cure. If this treatment strategy should prove correct, omitting radiotherapy could simplify treatment and may mean fewer side effects.

Study Chair:

Dr. Michael Montemurro, CHUV, +41 (21) 314 37 35

  • Contacts at the hospitals

  • Inclusion criteria

    • Age ≥ 18 years at diagnosis

    • Diagnosis of rectal adenocarcinoma

    • Radiologically measurable or clinically evaluable disease as defined in the protocol

    • ECOG Performance Status (PS): 0, 1 or 2

    • For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection

    • Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon

    • Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.

    • Clinical Stage: T2N1, T3N0, T3N1.

      • N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.

      • Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis.

    • The following laboratory values obtained ≤ 28 days prior to registration:

      • Absolute neutrophil count (ANC) ≥ 1500/mm^3

      • Platelet count ≥ 100,000/mm^3

      • Hemoglobin > 8.0 g/dL

      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

      • SGOT (AST) ≤ 3 x ULN

      • SGPT (ALT) ≤ 3 x ULN

      • Creatinine ≤1.5 x ULN

    • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

    • Patient of child-bearing potential is willing to employ adequate contraception

    • Provide informed written consent

    • Willing to return to enrolling medical site for all study assessments

  • Exclusion criteria

    • Clinical T4 tumors

    • Primary surgeon indicates need for abdominoperineal (APR) at baseline

    • Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)

    • Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).

    • Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.

    • Any prior pelvic radiation
    • Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma in-situ of the cer

    • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.

      •  Pregnant women

      • Nursing women
      • Men or women of childbearing potential who are unwilling to employ adequate contraception
    •  Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Locations for this trial:

Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Kantonsspital Winterthur
Brauerstrasse 15
0 8401 Winterthur
Klinik Hirslanden im Park
Seestrasse 259
0 8002 Zürich
Klinik Hirslanden Zürich
Witellikerstrasse 40
0 8032 Zürich
Centre Hospitalier Universitaire Vaudois CHUV
Rue du Bugnon 46
0 Lausanne